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ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is a prescription medicine used to treat adults who are addicted to opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy. Call (855) 982-7658 for more information on ZUBSOLV.

Adverse events were similar across treatments1

Treatment-related, treatment-emergent adverse events (TEAEs) in ≥2% of patients Day 3 through Day 15 by system organ class (safety population)

System Organ Class

Patients with any TEAEs

Gastrointestinal disorders

Constipation

Nervous system disorder

Headache

ZUBSOLV

42 (11.8%)

22 (6.2%)

10 (2.8%)

12 (3.4%)

5 (1.4%)

Suboxone film

37 (10.8%)

18 (5.2%)

12 (3.5%)

12 (3.5%)

7 (2.0%)

The percentages of patients with treatment-related TEAEs were similar between the 2 treatments (post Day 3 through Day 15, 11.8% versus 10.8% for ZUBSOLV and Suboxone film, respectively)

Gastrointestinal effects were minimal with constipation reported in <5% of patients in the study. Similar improvements were demonstrated in constipation symptoms from baseline to Day 15 in both groups.

Nervous system disorders were similar between groups, all were mild to moderate in severity with headache being the most commonly reported event

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What is ZUBSOLV®?

ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is a prescription medicine used to treat adults who are addicted to opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.

IMPORTANT SAFETY INFORMATION

Do not take ZUBSOLV if you are allergic to buprenorphine or naloxone as serious negative side effects, including anaphylactic shock, have been reported.

ZUBSOLV can cause serious and life-threatening breathing problems. Call your healthcare provider right away or get emergency help if (a) you feel faint, dizzy, or confused; (b) your breathing gets much slower than is normal for you; (c) you feel sleepy and uncoordinated; (d) you have blurred vision; (e) you have slurred speech; (f) you cannot think well or clearly; or (g) you have slowed reflexes and breathing. In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with ZUBSOLV.

ZUBSOLV contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your healthcare provider can tell you more about the difference between physical dependence and addiction. Do not stop taking ZUBSOLV without talking to your healthcare provider. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.

Your healthcare provider may monitor liver function before and during treatment with ZUBSOLV.

Keep ZUBSOLV in a secure place away from children. If a child accidentally takes ZUBSOLV, this is a medical emergency and can result in death. Get emergency help right away.

The most common side effects of ZUBSOLV include: headache, drug withdrawal syndrome, nausea, decrease in sleep (insomnia), vomiting, pain, increased sweating, swelling of the extremities, and constipation. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Do not switch from ZUBSOLV to other medicines that contain buprenorphine without talking with your healthcare provider. The amount of buprenorphine in a dose of ZUBSOLV is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of buprenorphine that may be different than other buprenorphine-containing medicines you may have been taking.

ZUBSOLV is not for occasional or “as needed” use. An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using ZUBSOLV. Ask your healthcare provider what you should do if you are taking one of these. You should not drink alcohol while taking ZUBSOLV, as this can lead to loss of consciousness or even death.

Before taking ZUBSOLV, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Before taking ZUBSOLV, tell your healthcare provider if you are pregnant or plan to become pregnant. If you take ZUBSOLV while pregnant, your baby may have signs of withdrawal at birth and that withdrawal is treatable. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

Before taking ZUBSOLV, tell your healthcare provider if you are breastfeeding or plan to breastfeed. ZUBSOLV can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take ZUBSOLV. Monitor your baby for increased sleepiness and breathing problems.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how ZUBSOLV affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take ZUBSOLV.

ZUBSOLV is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your ZUBSOLV in a safe place to protect it from theft. Never give your ZUBSOLV to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.

To report negative side effects associated with taking ZUBSOLV, please call 1-888-982-7658. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About ZUBSOLV

ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the treatment of opioid dependence. ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Treatment should be initiated under the direction of healthcare providers who are certified under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).